7 People Infected with CRE at UCLA
Our lawyers are investigating an outbreak of CRE infections at UCLA linked to the use of a specialized endoscope called a duodenoscope, which is used for endoscopic retrograde cholangiopancreatography (ERCP).
Carbapenem-resistant Enterobacteriaceae (CRE) is a drug-resistant superbug that is often fatal. To date, 7 people have tested positive, and 2 of them tragically died. Over 170 patients at UCLA may have been exposed to CRE via contaminated ERCP endoscopes. The FDA has issued a safety communication regarding these devices pose a risk of transmitting CRE, stating that these products are not adequately cleaned and sterilized using the manufacturers instructions.
The patients sickened in this outbreak and the families of the people killed need answers. A lawsuit is often the only way to get corporate documents that will help answer the following and other questions:
When did the manufacturer of the endoscope and UCLA know that there was a risk of CRE to patients?
How were the endoscopes used on the patients sterilized and why weren’t other methods of cleaning used to ensure patient safety?
UCLA has begun to notify 179 other patients who were treated from October of 2014 to January of 2015.
Why Are the Endoscopes Transmitting CRE?
The endoscopes that are the source of the UCLA outbreak have been linked to past outbreaks. It has taken years for the FDA to acknowledge that there is a problem, but, in the wake of this outbreak, it finally has: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication.
The problem is that these ERCP endoscopes (inserted down the throats of about 500,000 patients a year) can’t be cleaned well enough to prevent transmission of disease using the instructions provided by the manufacturers. They are used to draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.
ERCP endoscopes (also called duodenoscopes) are flexible, lighted tubes threaded down the throat, through the stomach, and into the top of the small intestine (the duodenum). The part that is not getting sterilized is the movable “elevator” mechanism at the tip (see the image below). Because it can move at an angel, it allows the instrument to access the ducts and treat problems with fluid drainage.
The FDA has acknowledge:
- Some parts of the scopes may be extremely difficult to access and
- Effective cleaning of all areas of the duodenoscope may not be possible.
So every patient that this instrument is used on is at risk for CRE or another deadly infection–EVERY PATIENT.
To make matters worse, the manufacturers’ instructions do not even come close to sterilizing the product.
For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush, according to the FDA. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.
The FDA is recommending further cleaning procedures. But, at the same time, the agency has admitted that 100% sterilization may not be attainable.
What Happened at UCLA?
UCLA discovered the problem at the hospital when it found CRE in one patient and traced it to these endoscopes.
Before this, hospital procedure was to clean the scopes according to standards stipulated by the manufacturer, according to university officials. It has now changed how it disinfects them.
Below is information regarding past outbreaks linked to these ERCP endoscopes:
- At least 32 patients at Virginia Mason Medical Center were sickened between 2012 and 2014, and 11 of them died;
- From March to July 2013, nine patients with positive cultures for E. coli were identified in northeastern Illinois.